FKH · Class II · 21 CFR 876.5820

FDA Product Code FKH: Solution-test Standard-conductivity, Dialysis

Leading manufacturers include Mesa Laboratories, Inc. and H & S Technical Services.

8
Total
8
Cleared
60d
Avg days
1981
Since

FDA 510(k) Cleared Solution-test Standard-conductivity, Dialysis Devices (Product Code FKH)

8 devices
1–8 of 8
Cleared Aug 05, 2019
TDS Standard Solution
K191496
Mesa Laboratories, Inc.
Gastroenterology & Urology · 61d
Cleared Apr 18, 2013
COMINED STANDARD SOLUTION
K130100
Mesa Laboratories, Inc.
Gastroenterology & Urology · 93d
Cleared Jul 02, 2004
H&S-CONDUCTIVITY STANDARD SOLUTION
K041636
H & S Technical Services
Gastroenterology & Urology · 15d

About Product Code FKH - Regulatory Context